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Senior Specialist Documentation

Job details
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Senior Specialist Documentation
* Requisition ID: WD141766
* Position: Full-Time Regular
* Open date: Nov 30, 2017 3:38 PM
* Functional area: Quality
* Location:
Wavre, Wavre
* Required degrees: Not Indicated
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Basic qualifications:
-University degree (Biotechnology, Agronomy, Chemistry or Pharmacy, Industrial or Civil engineering)
-Proven experience and references in a pharmaceutical, biological or biotechnical environment.
-At least 3 to 5 years of experience in Production, Validation or QA in a biopharmaceutical industry

Preferred qualifications:
-Filling or visual inspection equipment validation, Autoclave and Cleaning Validation knowledge would be considered an added value.

Details:
Job Purpose:

-Provide QA support to validation activities
-Take the responsibility for QA in new projects
-Assure regulatory inspection readiness (L2 - L3/L4)

Key Responsibilities:

-Ensure the compliance in all validation activities
-Approve change control (linked to project/ validation )
-Approve the validation documentation regarding the GMP requirements and the GSK vaccines procedures : URB - Basic design
-Approve the design qualification according to the GMP requirements and the Basic design
-Own and write the Validation master plan of projects
-Review/Approve IQ/OQ/PQ Protocols and reports (including raw data)
-Approval of risk assessment
-Ensure timely escalation to Management of critical issues during validation and / or project
-Review and approve deviations and the potential CAPA plan issued from deviation or inspection
-Perform internal audit (L1) of validation activities
-Contribute to external audit (L3 corporate/L4 Belgium …) : before - during - after
-Ensure implementation of validation related commitments towards internal/external inspections
-Write, review and approve the system periodic review
-Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
-Provide a compliance expertise in MPU projects
-Ensure QA oversight of Facility project from URS up to SAT
-Ensure the compliance in the Projects & Attend all project meetings as QA expert
-Work in autonomy with GSK supervision/coaching

Knowledge :
-Good interpersonal relationship skills
-Good oral and written communication skills in French & English
-Problem solving and achievement oriented
-Team spirit

Challenges :
The MPU FVI is a GSK filling site of vaccines in vials and syringes. The building has 4 major filling lines : 2 vials lines and 2 syringes lines, equipped with :
For vials : a vial washing and siliconisation machine, a depyrogenation tunnel followed by an aseptic filling line under Isolator technology. The second line has then 4 lyophilisation machines before capping and visual inspection. For both lines, visual inspection is executed on Seidenader machines. For syringes : Two aseptic filling lines under Isolator technology are installed and for both lines, visual inspection is executed on Seidenader machines.

Your role is to become the responsible QA involved in the validation for the filling and visual inspection (VI) of WN16, after training to the current GSK vaccines procedures and the necessary qualifications needed for the job.

Our Offer:

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.

The Department:

Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.

Our Company:

GSK is one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.

Senior Specialist Documentation

GlaxoSmithKline, Wavre
Employment type: 
Permanent, Contract